FDA 510(k)

機器人整合儀器

K 號：K233256 · 2024-06-17

決定日期2024-06-17

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Robotic Integration Instruments is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2024-06-17 under 510(k) number K233256. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Robotic Integration Instruments?

Robotic Integration Instruments is a medical device that received FDA 510(k) clearance on 2024-06-17. The listed applicant is DePuy Synthes. The 510(k) number is K233256.

When did Robotic Integration Instruments receive FDA 510(k) clearance?

Robotic Integration Instruments received FDA 510(k) clearance on 2024-06-17, under 510(k) number K233256.

Who is the listed applicant for Robotic Integration Instruments?

The FDA 510(k) record lists DePuy Synthes as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Robotic Integration Instruments?

The FDA product code for Robotic Integration Instruments is OLO.

其他以 DePuy Synthes 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K233696DePuy Synthes 後退式股骨釘先進系統 K233255CROSSNAV導航啟用儀器 K233254TELIKEN 系統導航準備儀器 K233665德普伊辛斯 VOLT Mini 適應性骨折板系統，德普伊辛斯 VOLT 小型骨折板系統 K231922德普伊合成 MAXFRAME 自動結構系統 K221809DePuy Synthes 3.5mm 骨盆內腔骨盂系統

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相關器械（代碼：OLO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262506Remex脊椎手術導航 - 適用儀器Remex Medical Corp.K261410Navbit MARQ (PRD-001-SUP（仰臥登錄套件），PRD-001-LAT（側臥登錄套件）)Suite 201, National Innovation Centre K261205脊椎藝術導航儀器系統Spineart SA K261024TMINI 微型機器人系統THINK Surgical, Inc.K262121離子-L導航儀器SurGenTec, LLC K261113Op.n™脊椎導航與機械導引Ecential Robotics

官方來源

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